Poisons Standard Amendment No. 3 of 2012

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01685 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

Poisons Standard Amendment No. 3 of 2012

The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The TG Act also provides for a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of poisons in Australia.  The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act.

Subsection 52D (2) of the TG Act authorises the Secretary to the Department of Health and Ageing, or a delegate of the Secretary, to amend the current Poisons Standard (known as the Standard for the Uniform Scheduling of Medicines and Poisons) or to prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.

Part 6-3 of the TG Act provides the basis for a uniform system of access controls for goods containing scheduled substances.  The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety.  The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse or abuse of, scheduled substances.  The TG Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (the ACMS) (section 52B) and the Advisory Committee on Chemicals Scheduling (the ACCS) (section 52C), which provide advice and make recommendations to the Secretary (or a delegate of the Secretary) on matters relating to medicines and chemicals scheduling decisions.

The Poisons Standard consists of decisions of the Secretary, or a delegate of the Secretary, regarding the classification of poisons into nine different Schedules signifying the degree of control recommended to be exercised over their availability to the public.

The purpose of this instrument is to amend the Poisons Standard 2012.  The amendments to the Poisons Standard 2012 out in Schedule 1 of this instrument consist of decisions made by a delegate of the Secretary.  These amendments commence on 1 September 2012.

The Schedules contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes, which enables restrictions to be placed on the supply of scheduled substances to the public, according to the degree of risk and the degree of control recommended to be exercised over their availability in the interest of public health and safety.  

The Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the TG Act.

For example, the TG Act and Regulations prohibit the publication of advertisements to consumers about prescription medicines included in Schedule 4 or 8 of the Poisons Standard or over the counter medicines that are included in Schedule 3 and not included in Appendix H of the Poisons Standard. The advertising of substances included in Schedule 9 or Appendix C of the Poisons Standard is also prohibited.

The amendments to the Poisons Standard 2012 as set out in this instrument consist of changes to existing entries and the inclusion of a small number of  specified substances in the Poisons Standard for the first time.

A number of these changes were made following the provision of advice from the ACMS and the ACCS, and in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 for amending the Poisons Standard when a proposed amendment is referred to an expert advisory committee.  The Scheduling Policy Framework (SPF) provides guidance to assist delegates in making a decision on whether a matter would benefit from being referred to an advisory committee for advice.  A copy of the SPF is available from http://www.tga.gov.au/industry/scheduling-spf.htm.

Public comment was invited on those matters referred to the ACMS and the ACCS, which related to proposals to amend the Poisons Standard in relation to the following substances:

  • adrenaline, ciclopirox, cyflufenamid, diethylphthalate, dimethylphthalate, flonicamid, formaldehyde, loratadine and zinc borate.  The invitation to comment in relation to these substances was advertised on the TGA website (www.tga.gov.au) from 14 December 2011, and closed on 19 January 2012.  Public submissions were taken into consideration at the February 2012 meetings of the ACCS and the ACMS.  Further public comment was subsequently invited on the delegate’s interim decisions on 26 April 2012, with a closing date of 10 May 2012.  The delegate’s final decisions in relation to these matters were published on the TGA website on 30 May 2012.  The delegate decided that these decisions should be implemented from 1 September 2012.

Other amendments set out in this instrument added the new substances axitinib, bistrifluron, cobicistat, elvitegravir, and sedaxane to the Poisons Standard for the first time.  These decisions were delegate-only decisions that were not open to public consultation, as they were considered to be sufficiently straightforward, in accordance with the guidelines in the SPF, as to not require public consultation.

The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA).  However, section 42 (disallowance) of the LIA does not apply (refer to subsection 52D(4A) of the TG Act).

In relation to compatibility with human rights, it is considered that Poisons Standard Amendment No. 3 of 2012 is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is attached.

ATTACHMENTS

1.  Statement of compatibility for a legislative instrument that does not raise any human rights issues (Poisons Standard Amendment No. 3 of 2012).

 

 

 

 

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, establishes a regulatory framework to ensure the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. This Act addresses the need for a comprehensive system to control the use and distribution of therapeutic goods, including medicines and poisons, by providing a uniform approach for the States and Territories to regulate their availability and accessibility. The Therapeutic Goods Administration is responsible for administering this Act. The Poisons Standard Amendment No. 3 of 2012 was introduced to refine and update the Poisons Standard, which classifies substances into schedules that dictate the level of control required for their distribution to the public. This amendment aims to harmonise the scheduling of certain substances with public health and safety objectives, and follows recommendations from expert advisory committees and public consultation. The changes include adjustments to existing entries and the addition of new substances to the Poisons Standard, reflecting the evolving understanding of the risks associated with various substances and ensuring that regulatory measures are both effective and proportionate.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) governs the quality, safety, efficacy, and availability of therapeutic goods in Australia, as well as the control of poisons within the country. Under the TG Act, the Therapeutic Goods Administration (TGA) administers the legislation and is responsible for maintaining the Poisons Standard, which classifies substances into schedules to restrict their availability to the public based on risk and safety considerations. This Act applies to therapeutic goods used in or exported from Australia and provides a uniform system of access controls for goods containing scheduled substances, aiming to minimise the risks of poisoning and misuse. The Act also establishes two advisory committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), which provide advice to the Secretary on scheduling decisions. The Poisons Standard, referenced in State and Territory legislation, is instrumental in placing restrictions on the supply of scheduled substances, and the Commonwealth also uses it for regulatory and enforcement purposes under the TG Act. The Poisons Standard Amendment No. 3 of 2012 amends the existing Poisons Standard, incorporating changes to existing entries and adding new substances to the Standard for the first time. These amendments were made by a delegate of the Secretary, taking into account advice from the ACMS and ACCS, and are intended to be implemented from 1 September 2012. The changes include modifications to the scheduling of substances such as adrenaline, ciclopirox, and formaldehyde, among others, as well as the addition of substances like axitinib and sedaxane. The amendment process involved public consultation for certain substances, while other additions were considered straightforward enough to bypass public consultation, in line with the Scheduling Policy Framework (SPF). This instrument is a legislative one under the Legislative Instruments Act 2003, although the disallowance provision does not apply to it, as per subsection 52D(4A) of the TG Act. Additionally, the amendments are deemed compatible with human rights, as evidenced by the attached Statement of Compatibility.

Key Provisions

The main operative sections of this legislation pertain to the Poisons Standard and its amendments, particularly those outlined in Schedule 1 of the instrument. This standard, which consists of decisions regarding the classification of poisons into various schedules, is critical for regulating the availability of substances in Australia. These decisions are made by a delegate of the Secretary to the Department of Health and Ageing under the authority granted by the Therapeutic Goods Act 1989 (TG Act) (subsection 52D(2)). The amendments introduced by this instrument, which include changes to existing entries and the addition of new substances, are effective from 1 September 2012. The Poisons Standard is integral to the regulatory framework for controlling the supply of scheduled substances to the public, ensuring public health and safety. The obligations imposed by this Act on the parties or entities it governs primarily revolve around compliance with the Poisons Standard. This includes adhering to the classifications of substances, which dictate the level of control over their availability. For example, under the TG Act and associated regulations, there are strict prohibitions on advertising certain scheduled substances to the public. This necessitates that entities involved in the supply or advertising of therapeutic goods ensure they are compliant with the current Poisons Standard. Additionally, any entity involved in the manufacturing, importing, or distribution of scheduled substances must follow the regulatory requirements set forth by the Therapeutic Goods Administration (TGA) to prevent misuse and ensure safe handling. The legislation also outlines various offences and penalties for breaches of the Poisons Standard. For example, the TG Act and associated regulations prohibit advertising prescription medicines included in Schedule 4 or 8, over-the-counter medicines in Schedule 3 not in Appendix H, and substances in Schedule 9 or Appendix C. Breaches of these provisions could result in civil or criminal penalties, although the specific penalties are not detailed in the explanatory statement. The severity of the penalties would depend on the nature and extent of the breach, as well as any relevant jurisdictional guidelines. The amendments made by this instrument are intended to enhance public safety by ensuring that substances are appropriately classified and controlled, thereby reducing the risk of poisoning and misuse.

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